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entitled 'President's Emergency Plan For Aids Relief: Millions Being
Treated, but Better Information Management Needed to Further Improve
and Expand Treatment' which was released on July 8, 2013.
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United States Government Accountability Office:
GAO:
Report to Congressional Requesters:
July 2013:
President's Emergency Plan For Aids Relief:
Millions Being Treated, but Better Information Management Needed to
Further Improve and Expand Treatment:
GAO-13-688:
GAO Highlights:
Highlights of GAO-13-688, a report to congressional requesters.
Why GAO Did This Study:
PEPFAR, first authorized in 2003, has supported significant advances
in HIV/AIDS prevention, treatment, and care in over 30 countries,
including directly supporting treatment for about 5.1 million people;
however, millions more people still need treatment. Congress
reauthorized PEPFAR in 2008—-authorizing up to $48 billion over 5
years-—directing OGAC to continue expanding the number of people
receiving care and treatment through PEPFAR while also making it a
major policy goal to help partner countries develop independent,
sustainable HIV programs. As a result, PEPFAR began shifting efforts
from directly providing treatment services toward support for
treatment programs managed by partner countries. GAO completed a
series of reports between 2011 and 2013 covering PEPFAR treatment
program costs, results, and supply chains for ARV drugs, and PEPFAR
program evaluations and planning and reporting. GAO was asked to
summarize the key themes of these reports relating to (1) PEPFAR’s
successes in expanding and improving treatment programs and (2)
information management challenges to further improving and expanding
treatment programs.
What GAO Found:
The President’s Emergency Plan for AIDS Relief (PEPFAR) has expanded
treatment programs and increased their efficiency and effectiveness.
* According to the Department of State’s (State) Office of the U.S.
Global AIDS Coordinator (OGAC), from 2005 to 2011, PEPFAR’s per-
patient treatment costs declined from about $1,053 to about $339.
PEPFAR’s increasing use of generic products and declining
antiretroviral (ARV) drug prices have been a key source of savings.
Programs also benefited from economies of scale and program maturity.
* PEPFAR and partner countries have achieved substantial increases in
the number of people on ARV drug treatment and have increased the
percentage of eligible people receiving treatment. According to OGAC,
treatment retention rates are at or above 80 percent at PEPFAR-
supported treatment facilities in 10 partner countries.
* PEPFAR has also worked with U.S. implementing agencies,
international donors, and partner countries to increase the efficiency
and reliability of ARV drug supply chains.
* PEPFAR implementing agencies have evaluated a wide variety of PEPFAR
program activities, demonstrating a clear commitment to program
improvements.
Better information management is crucial to helping countries improve
and expand treatment programs to meet the needs of the estimated 23
million people eligible for ARV treatment under 2012 international
guidelines. GAO’s reviews of PEPFAR treatment costs, results, and ARV
drug supply chains have revealed limitations in the completeness,
timeliness, and consistency of key program information. GAO also found
important information lacking in PEPFAR program evaluations, plans,
and results reporting. GAO has made a series of recommendations to
improve the quality of this information in order to make PEPFAR
programs more efficient and effective. The potential benefits that
could be realized if GAO’s recommendations are implemented include the
following:
* More complete and timely cost data could help countries manage costs
and plan treatment expansion more effectively.
* More consistent, complete, and timely information on treatment
results could enhance the quality of treatment programs, including
patient, clinic, and program management.
* Plans to help countries improve inventory management and record
keeping and tracking their progress could help supply chains operate
more efficiently.
* A more systematic and rigorous approach to planning and conducting
program evaluations could result in evaluations that better inform
PEPFAR stakeholders about how to improve programs.
* OGAC could provide better context for understanding PEPFAR’s
achievements and challenges by comparing program results with targets
and discussing efforts to ensure the quality of reported information.
What GAO Recommends:
GAO previously made 13 recommendations to State to improve PEPFAR
treatment programs, program evaluations, and reporting of program
results. State generally agreed with these recommendations and has
begun implementing some of them.
View GAO-13-688. For more information, contact David Gootnick at (202)
512-3149 or gootnickd@gao.gov, or Marcia Crosse at (202) 512 7114 or
crossem@gao.gov.
[End of section]
Contents:
Letter:
Background:
PEPFAR Has Helped Countries Expand Treatment Programs and Increase
Their Efficiency and Effectiveness:
Better Information Management Is Key to Helping Countries Improve and
Expand Treatment Programs:
Concluding Observations:
Agency Comments:
Appendix I: GAO Contacts and Staff Acknowledgments:
Related GAO Products:
Figures:
Figure 1: Average Prices for Three Comparable First-Line ARV Treatment
Regimens, from Third Quarter of Fiscal Year 2005 through Third Quarter
of Fiscal Year 2011:
Figure 2: Number of People on Treatment Directly Supported by PEPFAR,
Fiscal Years 2004-2012, and Total Number of People on Treatment in
Low- and Middle-Income Countries, Calendar Years 2004-2011:
Figure 3: Elements of PEPFAR Drug Supply Chain:
Abbreviations:
2008 Leadership Act: Tom Lantos and Henry J. Hyde United States Global
Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization
Act of 2008:
AEA: American Evaluation Association:
AIDS: acquired immunodeficiency syndrome:
ARV: antiretroviral:
CD4: cluster of differentiation antigen 4:
CDC: Centers for Disease Control and Prevention:
Global Fund: The Global Fund to Fight AIDS, Tuberculosis and Malaria:
GPRA: Government Performance and Results Act of 1993:
HHS: Department of Health and Human Services:
HIV: human immunodeficiency virus:
M&E: monitoring and evaluation:
NGO: nongovernmental organization:
OGAC: Office of the U.S. Global AIDS Coordinator:
PEPFAR: President's Emergency Plan for AIDS Relief:
State: Department of State:
UNAIDS: Joint United Nations Programme on HIV/AIDS:
USAID: U.S. Agency for International Development:
WHO: World Health Organization:
[End of section]
GAO:
United States Government Accountability Office:
441 G St. N.W.
Washington, DC 20548:
July 8, 2013:
Congressional Requesters:
A decade since it was established in 2003 and nearing the end of its
second 5-year authorization,[Footnote 1] the President's Emergency
Plan for AIDS Relief (PEPFAR) has supported the rapid expansion of
programs that provide access to life-saving antiretroviral (ARV) drugs
and other treatment and care services to millions of people living
with HIV/AIDS in low-and middle-income countries. However, millions
more are still in need of treatment, and challenges remain as PEPFAR
transitions from an emergency program to supporting sustainable
treatment programs in partner countries.
As of September 2012, the Department of State's (State) Office of the
U.S. Global AIDS Coordinator (OGAC) reported that PEPFAR's
multibillion dollar investments in partner countries' programs had
provided treatment for about 5.1 million people, more than half of all
individuals enrolled in treatment in low-and middle-income
countries.[Footnote 2] As part of this assistance, PEPFAR purchased
over $1.2 billion in ARV drugs during fiscal years 2005 through 2011
to treat people living with HIV. In part because of this assistance,
the estimated number of AIDS-related deaths worldwide declined from
2.3 million in 2005 to 1.7 million in 2011, according to data reported
by the United Nations Joint Programme on HIV/AIDS (UNAIDS).
OGAC is leading PEPFAR's shift from an emergency program primarily
providing direct treatment to one that increasingly supports partner
countries' capacity to manage their treatment programs. In passing the
Tom Lantos and Henry J. Hyde United States Global Leadership Against
HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008 (2008
Leadership Act), Congress directed OGAC to continue to expand the
number of people receiving HIV care and treatment support while also
making it a major policy goal to build partner-country capacity to
deliver services and promote a transition toward greater
sustainability of country-owned HIV/AIDS programs.[Footnote 3] On the
basis of recent World Health Organization (WHO) guidelines, an
estimated 15 million people in low-and middle-income countries are
eligible for ARV treatment. Moreover, 23 million would be eligible if
programs expand eligibility to include groups such as all pregnant and
breastfeeding women and certain high-risk populations, consistent with
recommendations in 2012 updates to World Health Organization
guidelines.[Footnote 4] In December 2011, the President announced an
increase in PEPFAR's target for the number of people receiving
treatment directly supported by PEPFAR--from 4 million to 6 million by
the end of fiscal year 2013.[Footnote 5]
In 2013 we completed a series of reports on PEPFAR treatment programs
covering costs, results, and supply chains for ARV drugs.[Footnote 6]
In addition, we conducted other work in 2011 and 2012 on PEPFAR
evaluations and program planning and reporting.[Footnote 7] You asked
us to summarize the common themes from this body of work. This report
includes information on (1) PEPFAR's successes in expanding treatment
programs and increasing their efficiency and effectiveness, and (2)
information management challenges that need to be addressed in order
to further improve and expand treatment programs.
We performed the work on which this report is based in accordance with
generally accepted government auditing standards. Those standards
require that we plan and perform the audit to obtain sufficient,
appropriate evidence to provide a reasonable basis for our findings
and conclusions based on our audit objectives. We believe the evidence
obtained provides a reasonable basis for our findings and conclusions
based on our audit objectives. Detailed information on the scope and
methodology for each of the reports used to prepare this overview
appears in the respective reports.
Background:
PEPFAR Structure and Purpose:
PEPFAR's original authorization in 2003 established OGAC at State and
gave OGAC primary responsibility for the oversight and coordination of
all resources and international activities of the U.S. government to
combat the HIV/AIDS pandemic. OGAC also allocates appropriated funds
to PEPFAR implementing agencies, particularly the Department of Health
and Human Services' (HHS) Centers for Disease Control and Prevention
(CDC) and the U.S. Agency for International Development (USAID). CDC
and USAID obligate the majority of PEPFAR funds for HIV treatment,
care, and prevention activities through grants, cooperative
agreements, and contracts with selected implementing partners, such as
U.S.-based nongovernmental organizations (NGO) and partner-country
governmental entities and NGOs.[Footnote 8]
PEPFAR supports the national HIV response in more than 30 countries.
[Footnote 9] The levels and types of PEPFAR support for these
countries' treatment programs vary on the basis of each country's
capacity and the state of its HIV epidemic. For example, for a given
country's program, PEPFAR may directly deliver the majority of HIV
treatment services; it may be one of many entities delivering those
services; or it may primarily provide support to other partners such
as the country government and other bilateral and multilateral
organizations--for example, the Global Fund to Fight AIDS,
Tuberculosis and Malaria (Global Fund)--that also provide support to
HIV programs. Moreover, UNAIDS data indicate that support for HIV
programs in many countries is increasingly a mix of resources from the
country government, Global Fund, PEPFAR, and other donors.[Footnote
10] PEPFAR strategy stresses the importance of having the partner-
country government play the coordinating role.
HIV/AIDS Treatment:
PEPFAR supports a broad continuum of HIV care and treatment services
in partner countries. This continuum begins with HIV testing and the
counseling given to patients learning their HIV status. If patients
are HIV positive, their eligibility for treatment must be determined
on the basis of clinical criteria (symptoms associated with HIV),
laboratory criteria (strength of patients' immune systems),[Footnote
11] or both clinical and laboratory criteria. WHO establishes
international guidelines on when to initiate treatment for specific
groups of HIV-positive people, such as adult patients who have never
been on treatment, pediatric patients, and pregnant and breastfeeding
women. In November 2010, WHO updated its guidelines by reducing the
minimum eligibility threshold in its laboratory criteria[Footnote 12]
and by recommending treatment for all people coinfected with HIV and
tuberculosis, thereby expanding the number of people eligible for
treatment. Based on WHO guidelines, each country is expected to
establish country-specific guidelines on when to initiate treatment
for these groups. UNAIDS estimated at the end of 2011 that, on the
basis of WHO's 2010 guidelines, 15 million people in low-and middle-
income countries needed treatment; of these, an estimated 8 million
people are on treatment.
PEPFAR country teams report to OGAC semiannually, usually in May, and
annually, usually in November, on PEPFAR program results. These
reports, containing data and narratives, are intended to support
program monitoring, midcourse correction, and planning for subsequent
fiscal years. Data on PEPFAR program results also supply information
for OGAC's annual report to Congress on PEPFAR performance.[Footnote
13]
ARV Drug Supply Chains:
In the House committee report on the 2008 Leadership Act, Congress
directed OGAC to work with others[Footnote 14] to develop effective,
reliable public-sector drug supply chain management systems owned and
operated by partner countries and to provide ongoing technical
assistance and sustained support to ensure the functioning of such
systems.[Footnote 15] In addition to helping partner countries develop
and manage their own supply chains for ARV drugs and other health care
commodities, PEPFAR supplies ARV drugs directly in some countries
through supply chains operated by contractors.[Footnote 16] PEPFAR's
efforts to develop and augment partner countries' supply chain systems
are critical to support continued progress in the fight against HIV/
AIDS because inadequate or poorly functioning supply chains pose risks
to individual as well as to public health outcomes. Patients on
treatment receive daily doses of ARV drugs on a continuing, lifelong
basis. Skipped doses due to gaps in supply and expired or otherwise
unusable ARV drugs can lead to ineffective treatment and increased
viral resistance, necessitating newer, more expensive drugs.[Footnote
17] Inefficient supply chains can also waste scarce public health
resources. For example, overstocking of drugs can lead to waste as
drugs expire and can no longer be used, potentially resulting in fewer
patients receiving treatment.
PEPFAR Has Helped Countries Expand Treatment Programs and Increase
Their Efficiency and Effectiveness:
Our recent reports have concluded that PEPFAR has helped partner
countries expand treatment programs and increase program efficiency
and effectiveness. PEPFAR's per-patient treatment costs have declined
significantly, facilitating substantial increases in the number of
people on ARV treatment. In addition, PEPFAR has helped partner
countries increase the percentage of eligible people receiving
treatment and has reported high treatment retention rates at
facilities in some countries. PEPFAR has also worked with U.S.
implementing agencies, international donors, and partner countries to
increase the efficiency and reliability of ARV drug supply chains.
Declining Per-Patient Treatment Costs:
According to OGAC, PEPFAR's per-patient treatment costs declined from
about $1,053 to about $339 from 2005 to 2011, based on budget
calculations. As we reported, detailed studies of the estimated costs
of providing HIV treatment services in eight countries also show
declining per-patient treatment costs. Purchasing generic ARV drugs,
together with declining drug prices, has led to substantial savings.
OGAC estimates that PEPFAR has saved $934 million since fiscal year
2005 by buying generic versions of ARV drugs instead of equivalent
branded products. Moreover, declining prices for specific ARV products
have led to declining prices for the ARV treatment regimens
recommended for use in resource-limited settings. For example, figure
1 shows how average prices have declined for three comparable first-
line treatment regimens.[Footnote 18]
Figure 1: Average Prices for Three Comparable First-Line ARV Treatment
Regimens, from Third Quarter of Fiscal Year 2005 through Third Quarter
of Fiscal Year 2011:
[Refer to PDF for image: multiple line graph]
Cost per patient:
Date: 2005, Q3;
Tenofovir: $808;
Stavudine: $555.
Date: 2005, Q4;
Tenofovir: $630;
Zidovudine: $663;
Stavudine: $470.
Date: 2006, Q1;
Tenofovir: $440;
Zidovudine: $442;
Stavudine: $274.
Date: 2006, Q2;
Tenofovir: $621;
Zidovudine: $639;
Stavudine: $420.
Date: 2006, Q3;
Tenofovir: $431;
Zidovudine: $422;
Stavudine: $290.
Date: 2006, Q4;
Tenofovir: $354;
Zidovudine: $280;
Stavudine: $180.
Date: 2007, Q1;
Tenofovir: $341;
Zidovudine: $350;
Stavudine: $168.
Date: 2007, Q2;
Tenofovir: $356;
Zidovudine: $337;
Stavudine: $198.
Date: 2007, Q3;
Tenofovir: $329;
Zidovudine: $319;
Stavudine: $162.
Date: 2007, Q4;
Tenofovir: $316;
Zidovudine: $238;
Stavudine: $126.
Date: 2008, Q1;
Tenofovir: $327;
Zidovudine: $232;
Stavudine: $141.
Date: 2008, Q2;
Tenofovir: $317;
Zidovudine: $242;
Stavudine: $127.
Date: 2008, Q3;
Tenofovir: $258;
Zidovudine: $289;
Stavudine: $112.
Date: 2008, Q4;
Tenofovir: $235;
Zidovudine: $208;
Stavudine: $109.
Date: 2009, Q1;
Tenofovir: $253;
Zidovudine: $204;
Stavudine: $106.
Date: 2009, Q2;
Tenofovir: $271;
Zidovudine: $216;
Stavudine: $127.
Date: 2009, Q3;
Tenofovir: $289;
Zidovudine: $160;
Stavudine: $90.
Date: 2009, Q4;
Tenofovir: $195;
Zidovudine: $190;
Stavudine: $119.
Date: 2010, Q1;
Tenofovir: $178;
Zidovudine: $168;
Stavudine: $92.
Date: 2010, Q2;
Tenofovir: $169;
Zidovudine: $162;
Stavudine: $105.
Date: 2010, Q3;
Tenofovir: $162;
Zidovudine: $155;
Stavudine: $85.
Date: 2010, Q4;
Tenofovir: $158;
Zidovudine: $157;
Stavudine: $111.
Date: 2011, Q1;
Tenofovir: $141;
Zidovudine: $147;
Stavudine: $79.
Date: 2011, Q2;
Tenofovir: $138;
Zidovudine: $147;
Stavudine: $78.
Q3;
Tenofovir: $140;
Zidovudine: $145;
Stavudine: $92.
Source: GAO analysis of PEPFAR data.
Notes: Each first-line regimen shown is a combination of three
individual ARV products. WHO recommends that most patients starting
ARV treatment for the first time receive one of several first-line
regimens that combine three ARV drugs. (Second-line or other regimens
may later become necessary because people receiving ARV treatment can
experience serious side effects from some ARVs or develop strains of
HIV that are resistant to some or all of their ARVs.) In 2010, WHO
recommended that countries replace stavudine with tenofovir or
zidovudine in their national treatment guidelines. The stavudine-based
regimen includes stavudine, lamivudine, and nevirapine. The zidovudine-
and tenofovir-based regimens also include lamivudine and nevirapine
but replace stavudine with one of the currently recommended
alternatives. Some of these regimens can be built with fixed-dose
combination products that combine two or three ARVs into one pill.
Prices for regimens using fixed-dose combination products are not
shown.
[End of figure]
PEPFAR's analyses of data from eight country treatment-cost studies
indicate that per-patient costs also declined as programs realized
economies of scale while taking on new patients. Furthermore, the
analyses suggest that costs decreased as countries' treatment programs
matured, particularly in the first year after programs expanded, and
reduced one-time investments.
Expanded Treatment and Contributions to Treatment Quality:
Our recent work also concluded that per-patient cost savings have
facilitated substantial increases in the number of people on ARV
treatment. Since the end of fiscal year 2008 - the year it was
reauthorized - PEPFAR has directly supported ARV treatment for over
3.3 million additional people. Moreover, in fiscal year 2012, PEPFAR
added more people to ARV treatment than in any previous year. In
September 2012, an estimated 8 million were on ARV treatment in low-
and middle-income countries, of which PEPFAR directly supported about
5.1 million (see figure 2).
Figure 2: Number of People on Treatment Directly Supported by PEPFAR,
Fiscal Years 2004-2012, and Total Number of People on Treatment in
Low- and Middle-Income Countries, Calendar Years 2004-2011:
[Refer to PDF for image: stacked line graph]
Year: 2004;
Number of people on treatment in low- and middle-income countries
directly supported by PEPFAR: 66,700;
Total number of people on treatment in low- and middle-income
countries: 629,260.
Year: 2005;
Number of people on treatment in low- and middle-income countries
directly supported by PEPFAR: 249,200;
Total number of people on treatment in low- and middle-income
countries: 1,062,730.
Year: 2006;
Number of people on treatment in low- and middle-income countries
directly supported by PEPFAR: 541,300;
Total number of people on treatment in low- and middle-income
countries: 1,492,700.
Year: 2007;
Number of people on treatment in low- and middle-income countries
directly supported by PEPFAR: 1,091,600;
Total number of people on treatment in low- and middle-income
countries: 1,877,440.
Year: 2008;
Number of people on treatment in low- and middle-income countries
directly supported by PEPFAR: 1,743,600;
Total number of people on treatment in low- and middle-income
countries: 2,309,630.
Year: 2009;
Number of people on treatment in low- and middle-income countries
directly supported by PEPFAR: 2,485,300;
Total number of people on treatment in low- and middle-income
countries: 2,753,980.
Year: 2010;
Number of people on treatment in low- and middle-income countries
directly supported by PEPFAR: 3,195,000;
Total number of people on treatment in low- and middle-income
countries: 3,382,030.
Year: 2011;
Number of people on treatment in low- and middle-income countries
directly supported by PEPFAR: 3,905,500;
Total number of people on treatment in low- and middle-income
countries: 4,101,040.
Year: 2012;
Number of people on treatment in low- and middle-income countries
directly supported by PEPFAR: 5,057,500;
Total number of people on treatment in low- and middle-income
countries (projected): 4,400,000.
Source: PEPFAR and UNAIDS data,
Notes: We estimated the total number of people that received treatment
in 2012, because UNAIDS data for low-and middle-income countries are
reported for calendar years and were not available for 2012 at the
time of this report's publication. PEPFAR data are reported for U.S.
government fiscal years.
[End of figure]
PEPFAR and UNAIDS data indicate a steady increase in the number of
people on treatment, improved treatment coverage rates, and high rates
of patient retention at many facilities. Increases in the number of
people on treatment have helped improve partner countries' national
treatment coverage rates--generally defined as the percentage of
eligible people receiving treatment.[Footnote 19] According to the
most current UNAIDS and PEPFAR data available at the time of our April
2013 review,[Footnote 20] 8 of the 23 countries where PEPFAR directly
supported treatment services in 2011 achieved estimated treatment
coverage rates of 80 percent or more,[Footnote 21] and almost all of
the remaining countries have increased their estimated treatment
coverage rates since 2009, according to our analysis of UNAIDS data.
We also found that PEPFAR's additional contributions to partner
countries' treatment programs include technical assistance to build
capacity, such as implementing revised treatment guidelines, assisting
partner-country district and national health officials with treatment
facility oversight, and training and mentoring treatment facility
staff. In several PEPFAR partner countries, PEPFAR implementing
partners providing direct treatment services have begun transferring
stable patients to other treatment providers, including an often
expanding number of local public and private health clinics, many of
which receive PEPFAR-funded technical assistance and other support. In
part because of this PEPFAR assistance, these providers also have
begun increasing the number of people they enroll in treatment.
Retention, defined as the percentage of adults and children known to
be alive and on treatment 12 months after starting treatment, is used
by OGAC and PEPFAR country teams as a proxy for treatment program
quality. Of the 23 PEPFAR country teams directly providing treatment
services, 20 provided data on this indicator in their fiscal year 2012
reports to OGAC, and 10 of the 20 reported retention rates at or above
80 percent for facilities where PEPFAR implementing partners directly
support treatment services.
More Efficient and Reliable Drug Supply Chains:
Our work shows that PEPFAR has worked with U.S. implementing agencies,
international donors, and partner countries to increase the efficiency
and reliability of ARV drug supply chains. It has done so by improving
drug supply planning and procurement as well as in-country
distribution of drugs (see figure 3 for elements of the PEPFAR drug
supply chain).
Figure 3: Elements of PEPFAR Drug Supply Chain:
[Refer to PDF for image: illustration]
Information management:
PLanning;
Forecast;
Procurement;
Delivery in partner country;
Distribution;
Consumption;
Repeat cycle.
Source: GAO analysis of documents from PEPFAR implementing partners.
[End of figure]
First, PEPFAR has consolidated supply chains for ARV drugs by pooling
procurement across more than 20 partner countries to enhance
efficiency and reduce costs and has begun further consolidation with
other U.S. global health programs. Second, PEPFAR has improved
coordination among donors by creating an information-sharing network
to help detect and resolve supply gaps and other supply chain
weaknesses and by developing an emergency drug procurement mechanism.
Third, PEPFAR has provided partner countries with technical
assistance, such as assessment tools and training, to help them better
manage drug supply planning, procurement, and distribution. In each of
the three partner countries we visited for our April 2013 report,
PEPFAR's technical assistance has increased efficiencies by
strengthening specific steps in the supply chain process. For example,
in South Africa, which represents more than one-fifth of the total
world demand for ARV drugs, PEPFAR helped the government institute
procurement reforms that enabled it to cut in half the prices it pays
for these drugs. In Uganda and Kenya, PEPFAR implementing agencies
report that PEPFAR has helped implement streamlined distribution
networks and has implemented or is in the process of implementing
additional mechanisms to reduce or prevent shortages.
Better Information Management Is Key to Helping Countries Improve and
Expand Treatment Programs:
Our recent work has found that, as PEPFAR partner countries assume
greater responsibility for managing their treatment programs, better
information management remains crucial to helping countries improve
and expand treatment programs. Our reviews of PEPFAR treatment costs,
results, and ARV drug supply chains have revealed some limitations in
the completeness, timeliness, and consistency of key program
information. We also found important information lacking in PEPFAR
program evaluations, plans, and results reporting.
More Complete and Timely Cost Data Could Help Countries Manage Costs
and Plan Treatment Expansion More Effectively:
Despite substantial declines in per-patient treatment costs, it is
important that countries continue to improve the efficiency of their
programs to expand to meet the needs of the estimated 23 million
people eligible for ARV treatment under recent WHO guidelines. PEPFAR
uses two approaches to obtain treatment cost information: cost
estimation and expenditure analysis. These approaches provide
complementary information that can help partner countries expand
treatment and identify potential cost savings. However, as currently
applied, these approaches do not capture the full costs of treatment.
Cost estimation provides in-depth information, but data are limited
because detailed cost studies have been done in only eight partner
countries, at a small number of sites. Moreover, although treatment
programs are changing rapidly, key data for most of the studies are no
longer timely, since they were collected in 2006 and 2007. We reported
that PEPFAR does not have a plan for systematically conducting or
repeating cost studies in partner countries. Data from expenditure
analyses, while more timely, are limited because they do not include
non-PEPFAR costs. We concluded that without more timely and
comprehensive information on treatment costs, PEFPAR may be missing
opportunities to identify potential savings, which are critical for
expanding HIV treatment programs to those in need.
To improve PEPFAR's ability to help countries expand their HIV
treatment programs to address unmet need, and do so through the
efficient allocation of resources and effective program planning, we
recommended that State direct PEPFAR to develop a plan for (1)
expanding the use of in-depth cost studies to additional countries and
sites, where appropriate, and (2) broadening expenditure analysis to
include non-PEPFAR costs, as feasible.[Footnote 22] State generally
agreed with these recommendations, noting that PEPFAR is developing
guidance on an optimal schedule for evaluating costs to balance in-
depth analysis with more timely data from expenditure analysis, and
that it has collaborated with multilateral partners in a few countries
to plan expenditure analyses that will capture non-PEPFAR spending.
More Consistent, Complete, and Timely Information on Treatment Results
Could Enhance the Quality of Treatment Programs:
OGAC has reported on PEPFAR treatment program results primarily in
terms of (1) numbers of people on treatment directly supported by
PEPFAR, (2) percentages of eligible people receiving treatment, and
(3) percentages of people alive and on treatment 12 months after
starting treatment. However, these indicators do not provide complete
information about PEPFAR results. First, although the number of people
on treatment directly supported by PEPFAR grew from about 1.7 million
to 5.1 million in fiscal years 2008 through 2012, this indicator alone
does not provide all the information needed for assessing PEPFAR's
contributions to partner countries' treatment programs. Second,
although 10 PEPFAR country teams reported that percentages of people
alive and on treatment after 12 months exceeded 80 percent, data for
this indicator are not always complete and have other limitations.
[Footnote 23] To improve these data, according to OGAC officials, OGAC
clarified its guidance and conducted data quality assessments.
However, we found that OGAC has not yet established a common set of
indicators to monitor the results of PEPFAR's efforts to improve the
quality of treatment programs. For example, in the three countries we
visited, we found that PEPFAR implementing partners were using a wide
range of indicators to report on their quality assurance activities,
and that even where indicators were generally the same, definitions
varied.
Fully functioning monitoring and evaluation (M&E) systems are critical
for tracking results and ensuring treatment program effectiveness.
PEPFAR country teams assist partner countries in carrying out their
M&E responsibilities by providing staff, training, technical
assistance, and other support. With this assistance, partner countries
have made some progress in expanding and upgrading these M&E systems.
Nevertheless, we found that partner countries' M&E systems often are
unable to produce complete and timely data, thus limiting the
usefulness of these data for patient, clinic, or program management.
Our review concluded that OGAC has not yet established minimum
standards for partner countries' M&E systems, particularly relating to
data completeness and timeliness, in order for PEPFAR country teams to
assess those systems' readiness for use in treatment program
management and results reporting.
To ensure the outcomes and quality of treatment programs supported by
PEPFAR, we recommended that State direct OGAC to (1) develop a method
that better accounts for PEPFAR's contributions to partner-country
treatment programs, (2) establish a common set of indicators to
measure the results of treatment program quality improvement efforts,
and (3) establish a set of minimum standards for data generated by
partner countries' M&E systems.[Footnote 24] State generally agreed
with these recommendations, and stated that PEPFAR has recently begun
an effort to revise its monitoring, evaluation, and reporting
framework and is taking steps to develop a harmonized PEPFAR strategy
on treatment quality as well as taking steps to improve treatment
retention measurement, evaluation, and performance.
Establishing Plans to Help Countries Improve Inventory Management and
Track Progress Could Help Supply Chains Operate More Efficiently:
Evaluations of partner-country supply chains reflect weaknesses in
inventory controls and record keeping, which may increase the risk of
drug shortages, waste, and loss. OGAC has issued guidance for PEPFAR
emphasizing the importance of effective information management for
efficient ARV drug supply chain operations. However, 11 of the 16
supply chain evaluations we reviewed cited weaknesses in partner
countries' inventory controls; 7 of these 11 evaluations also cited
weaknesses in record keeping, including incomplete or inaccurate data
on the consumption of ARV drugs. These weaknesses can increase the
risks of drug shortages, waste, and loss of inventory. In one country
we reviewed, an evaluation team identified losses valued at about
$265,000. We determined that human resource constraints, including
heavy workload, inadequate training, and insufficient oversight,
contribute to these weaknesses, and that PEPFAR is addressing them
through technical assistance and training. However, OGAC does not
specifically require PEPFAR interagency teams in each country to
develop plans to strengthen inventory controls and record keeping. Nor
does OGAC require country teams to track the progress partner
countries are making in measuring ARV drug consumption, waste, and
loss. Thus, we concluded that OGAC cannot ascertain the extent of
partner-country supply chain weaknesses and take appropriate action to
mitigate risks. For PEPFAR and partner countries to continue expanding
treatment programs to serve up to 23 million eligible people, further
improving drug supply chains is critical, particularly the efficiency
of elements managed by partner countries. These improvements will
become increasingly important as partner countries assume more
responsibility for managing supply chains.
To help ensure that drug supply chains in PEPFAR partner countries
function efficiently and mitigate the risks of shortages and wasted
and lost drugs, we recommended that State direct OGAC to require
PEPFAR country teams to (1) develop and implement plans to help
partner countries improve inventory controls and record keeping and
(2) track the progress partner countries are making in measuring ARV
drug consumption, waste, and loss.[Footnote 25] State generally agreed
with the intent of both recommendations, and confirmed that inventory
controls are not optimized in all PEPFAR countries. State indicated
that it will further assess these controls and focus technical
assistance on improving them where they are found lacking. State also
noted that PEPFAR has begun a more systematic investment in health
supply chain metrics to identify risks and weaknesses in partner-
country supply chains and assess progress in reducing risks and
enhancing performance.
More Systematic and Rigorous Program Evaluations Could Better Inform
PEPFAR Stakeholders about How to Improve Programs:
OGAC, CDC, and USAID have evaluated a wide variety of PEPFAR program
activities, demonstrating a clear commitment to evaluation. However,
we found that the findings, conclusions, and recommendations were not
fully supported in many PEPFAR evaluations. Agency officials provided
us with nearly 500 evaluations addressing activities ongoing in fiscal
years 2008 through 2010 in all program areas relating to HIV/AIDS
treatment, prevention, and care. Our assessment of a nonrandom sample
of 7 OGAC-managed evaluations found that they generally adhered to
common evaluation standards, as did most of a nonrandom sample of 15
evaluations managed by CDC and USAID headquarters.[Footnote 26] Based
on this assessment, we determined that these evaluations generally
contained fully supported findings, conclusions, and recommendations.
However, based on a similar assessment of a randomly selected sample
taken from 436 evaluations provided by PEPFAR country and regional
teams, we estimated that 41 percent contained fully supported
findings, conclusions, and recommendations, while 44 percent contained
partial support and 15 percent were not supported.[Footnote 27] In
addition, while State, OGAC, CDC, and USAID have established detailed
evaluation policies, as recommended by the American Evaluation
Association (AEA), PEPFAR does not fully adhere to AEA principles
relating to evaluation planning, independence and qualifications of
evaluators, and public dissemination of evaluation results. For
example, OGAC does not require country and regional teams to include
evaluation plans in their annual operational plans, limiting its
ability to ensure that evaluation resources are appropriately
targeted. We therefore concluded that more systematic and rigorous
program evaluations could better inform PEPFAR stakeholders about how
to improve programs.
To enhance PEPFAR evaluations, we recommended that State direct OGAC
to work with CDC and USAID to (1) improve adherence to common
evaluation standards, (2) develop PEPFAR evaluation plans, (3) provide
guidance for assessing and documenting evaluators' independence and
qualifications, and (4) increase online accessibility of evaluation
results.[Footnote 28] State agreed with these recommendations and
noted steps it would take to implement them.
OGAC Could Provide Better Context for Understanding PEPFAR's
Achievements and Challenges:
OGAC, USAID, and CDC publicly issued plans and reports on PEPFAR
performance in recent years consistent with the 2008 Leadership Act
requirements and Government Performance and Results Act of 1993 (GPRA)
practices; however, we found that two key elements are lacking. First,
although OGAC has internally specified annual performance targets, its
most recent annual reports to Congress did not identify these targets
or compare annual results with them. According to the 2008 Leadership
Act, OGAC's annual reports on PEPFAR program results must include an
assessment of progress toward annual goals and reasons for any failure
to meet these goals.[Footnote 29] In addition, GPRA calls for federal
agency performance reports to compare program results with established
targets. We found that performance documents published by USAID,
jointly with State, and by CDC, report program targets and results for
two and four PEPFAR indicators, respectively. Second, we found that
OGAC's most recently published performance plans and reports do not
provide information on efforts to validate and verify reported data,
while USAID's and CDC's published performance documents cite such
efforts by OGAC. In addition, none of the plans or reports refer to
noted data reliability weaknesses or efforts to address these
weaknesses. GPRA and prior GAO work[Footnote 30] emphasize the
importance of providing information in public performance documents on
data verification and other efforts to address identified weaknesses.
Thus, we concluded that OGAC could provide better context for
understanding PEPFAR's achievements and challenges by comparing
program results with targets and discussing efforts to ensure the
quality of reported information.
To improve transparency and accountability, we recommended that State
direct OGAC to include in its annual report to Congress (1)
comparisons of annual PEPFAR results with established targets and (2)
information on efforts to verify and validate PEPFAR performance data
and address data limitations.[Footnote 31] OGAC partially agreed with
the first recommendation, pending discussions with stakeholders about
implementation issues and consequences, and agreed with the second
recommendation.
Concluding Observations:
PEPFAR is at a critical juncture as it transitions from providing
direct, emergency services to primarily providing guidance and advice
to help countries develop independent, sustainable programs. PEPFAR
has taken steps toward greater integration with partner-country health
systems, overall health systems strengthening, and greater partner-
country responsibility for addressing HIV/AIDS. If the recommendations
we have made for actions are implemented effectively, we believe these
actions will help ensure that PEPFAR continues to help partner
countries improve and expand treatment to more of the 23 million
people in low-and middle-income countries who are living with HIV/AIDS
and in need of treatment or who are in at-risk groups eligible for
treatment.
Agency Comments:
We provided a draft of this report to OGAC, USAID, HHS, and CDC for
review. We received limited technical information, which we
incorporated as appropriate.
We will send copies of this report to the Secretary of State and the
U.S. Global AIDS Coordinator and interested congressional committees.
The report also will be available at no charge on the GAO website at
[hyperlink, http://www.gao.gov].
If you or your staff have any questions about this report, please
contact me at (202) 512-3149 or gootnickd@gao.gov, or contact Marcia
Crosse at (202) 512-7114 or crossem@gao.gov. Contact points for our
Offices of Congressional Relations and Public Affairs may be found on
the last page of this report. GAO staff who made major contributions
to this report are listed in appendix I.
Signed by:
David Gootnick:
Director, International Affairs and Trade:
Signed by:
Marcia Crosse:
Director, Health Care:
List of Requesters:
The Honorable Lamar Alexander:
Ranking Member:
Committee on Health, Education, Labor, and Pensions:
United States Senate:
The Honorable Tom Coburn, MD:
Ranking Member:
Committee on Homeland Security and Governmental Affairs:
United States Senate:
The Honorable Richard Burr:
Ranking Member:
Subcommittee on Primary Health and Aging:
Committee on Health, Education, Labor, and Pensions:
United States Senate:
The Honorable Michael B. Enzi:
Ranking Member:
Subcommittee on Children and Families:
Committee on Health, Education, Labor, and Pensions:
United States Senate:
The Honorable Johnny Isakson:
Ranking Member:
Subcommittee on Employment and Workplace Safety:
Committee on Health, Education, Labor, and Pensions:
United States Senate:
[End of section]
Appendix I: GAO Contacts and Staff Acknowledgments:
GAO Contacts:
David Gootnick, (202) 512-3149 or gootnickd@gao.gov, or Marcia Crosse,
(202) 512-7114 or crossem@gao.gov.
Staff Acknowledgments:
In addition to the contacts named above, Jim Michels, Assistant
Director, Kay Halpern, and David Dayton made key contributions to this
report. In addition, Todd M. Anderson, Chad Davenport, David Dornisch,
Etana Finkler, Katherine Forsyth, Brian Hackney, Grace Lui, and Jane
Whipple provided technical assistance and other support.
[End of section]
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Footnotes:
[1] Congress first authorized PEPFAR in 2003. See United States
Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003,
Pub. L. No. 108-25, 117 Stat. 711; and Tom Lantos and Henry J. Hyde
United States Global Leadership Against HIV/AIDS, Tuberculosis, and
Malaria Reauthorization Act of 2008, Pub. L. No. 110-293, 122 Stat.
2918.
[2] In this report, "treatment" refers to the services delivered to
HIV-positive individuals who are receiving ARV drugs. The ARV drugs
used to treat these people were paid for by PEPFAR, other donors, and
partner-country governments.
[3] Pub. L. No. 110-293, §§ 301 and 403.
[4] For a broader description of the guidelines for treatment
eligibility, see World Health Organization, The Strategic Use of
Antiretrovirals to Help End the HIV Epidemic (Geneva, Switzerland:
2012).
[5] OGAC guidance defines PEPFAR direct results as achievements of the
PEPFAR program through its funded activities, as opposed to
achievements of all contributors to a partner country's HIV/AIDS
program.
[6] See GAO, President's Emergency Plan for AIDS Relief: Per-Patient
Costs Have Declined Substantially, but Better Cost Data Would Help
Efforts to Expand Treatment, [hyperlink,
http://www.gao.gov/products/GAO-13-345] (Washington, D.C.: Mar. 15,
2013); President's Emergency Plan for AIDS Relief: Shift toward
Partner-Country Treatment Programs Will Require Better Information on
Results, [hyperlink, http://www.gao.gov/products/GAO-13-460]
(Washington, D.C.: Apr. 12, 2013); and President's Emergency Plan for
AIDS Relief: Drug Supply Chains Are Stronger, but More Steps Are
Needed to Reduce Risks, [hyperlink,
http://www.gao.gov/products/GAO-13-483] (Washington, D.C.: Apr. 26,
2013).
[7] See GAO, President's Emergency Plan for AIDS Relief: Agencies Can
Enhance Evaluation Quality, Planning, and Dissemination, [hyperlink,
http://www.gao.gov/products/GAO-12-673] (Washington, D.C.: May 31,
2012) and President's Emergency Plan for AIDS Relief: Program Planning
and Reporting, [hyperlink, http://www.gao.gov/products/GAO-11-785]
(Washington, D.C.: July 29, 2011).
[8] Other implementing agencies include the Peace Corps and the
Departments of State, Defense, Labor, and Commerce. In addition, other
HHS offices and agencies receiving PEPFAR resources include the Office
for Global Affairs, the Food and Drug Administration, the Health
Resources and Services Administration, the National Institutes of
Health, and the Substance Abuse and Mental Health Services
Administration.
[9] This includes the 33 countries and three regions that developed
PEPFAR annual operational plans for fiscal year 2012. The 33 countries
were Angola, Botswana, Burundi, Cambodia, Cameroon, China, Côte
d'Ivoire, Democratic Republic of the Congo, Dominican Republic,
Ethiopia, Ghana, Guyana, Haiti, India, Indonesia, Kenya, Lesotho,
Malawi, Mozambique, Namibia, Nigeria, Russia, Rwanda, South Africa,
South Sudan, Swaziland, Tanzania, Thailand, Uganda, Ukraine, Vietnam,
Zambia, and Zimbabwe. The three regions were the Caribbean, Central
America, and Central Asia.
[10] UNAIDS reports that from 2010 to 2011 low-and middle-income
countries increased their domestic spending on HIV programs by 15
percent and that by the end of 2011 their domestic spending accounted
for the majority of all HIV spending for the first time.
[11] This is typically measured by CD4 (cluster of differentiation
antigen 4) count in a sample of blood. CD4 cells are a type of white
blood cell that fights infection. Along with other tests, the CD4
count helps determine the strength of the immune system, indicates the
stage of the HIV disease, guides treatment, and predicts the disease's
progress.
[12] WHO recommended treatment for all people with CD4 counts of less
than 350 cells/mm3. Prior to 2010, WHO's guidelines recommended
treatment for all people with CD4 counts of less than 200 cells/mm3.
Normal CD4 counts range from 500-1,000 cells/mm3.
[13] See GAO, President's Emergency Plan for AIDS Relief: Program
Planning and Reporting, [hyperlink,
http://www.gao.gov/products/GAO-11-785] (Washington, D.C.: July 29,
2011).
[14] These include the Partnership for Supply Chain Management Systems
(an association of entities with supply chain expertise), PEPFAR
partner countries, and nongovernmental organizations.
[15] The report also directed OGAC to provide technical assistance and
sustained support to ensure the functioning of existing supply chains
operated by nonpublic-sector entities, including humanitarian and
faith-based organizations. Committee on Foreign Affairs, Leadership
Act of 2008, H.R. Rep. No. 110-546, Part 1, at 54 (2008) (Supp. Rep.).
[16] For the purposes of this report, "supply chains" refers
specifically to distribution systems that supply ARV drugs and other
health care commodities needed by treatment programs. In some cases,
these commodities flow through distribution systems providing a wide
range of health care commodities, and in other cases, they flow
through distribution systems dedicated exclusively to HIV programs.
[17] In 2012, we examined the regulatory and policy requirements
intended to ensure the quality of drugs, including ARVs, procured with
U.S. aid funds, as well as the systems in place to monitor drug
quality in supply chains used by programs receiving U.S. foreign aid
funds, including PEPFAR. See GAO, Health Care: Ensuring Drug Quality
in Global Health Programs, [hyperlink,
http://www.gao.gov/products/GAO-12-897R] (Washington, D.C.: Aug. 1,
2012).
[18] Prices paid for a specific product can vary by country, year, and
the implementing partner. Because these price variations are driven by
various factors, PEPFAR is examining differences in prices paid by
implementing partners. According to PEPFAR officials, they are
focusing their analyses on variations within the same country in the
same year, to determine if the program can minimize these variations
in price and thereby achieve additional savings.
[19] This percentage is calculated by dividing the number of adults
and children currently receiving treatment by an estimate (typically
derived from epidemiological data and modeling) of the number of
adults and children eligible to receive treatment (i.e., those with
advanced HIV infection). Population coverage indicators generally
depict regional or national program results and are to be
disaggregated by age and sex.
[20] The most recent available information on national treatment
coverage is from UNAIDS. We consulted UNAIDS' most recent report on
the global AIDS epidemic and cross-referenced this information with
national treatment coverage data available on the UNAIDS website as
well as data in PEPFAR country teams' fiscal year 2011 annual reports
to OGAC. Data on China's 2011 national coverage rate were not
available from UNAIDS. In its fiscal year 2011 report to OGAC, the
PEPFAR country team provided information on China's 2010 national
treatment coverage rate, which we used for this report.
[21] Each country sets its own targets for national treatment coverage
rates. According to UNAIDS, most countries have set 80 percent as
their target for treatment coverage.
[22] GAO, President's Emergency Plan for AIDS Relief: Per-Patient
Costs Have Declined Substantially, but Better Cost Data Would Help
Efforts to Expand Treatment, [hyperlink,
http://www.gao.gov/products/GAO-13-345] (Washington, D.C.: Mar. 15,
2013).
[23] These limitations include differing ways of ascertaining and
defining treatment retention; lack of data for key populations at risk
of contracting HIV, such as children and adolescents, injecting drug
users, men who have sex with men, and sex workers; and minimal data on
long-term retention (after 24 months from the start of treatment).
[24] GAO, President's Emergency Plan for AIDS Relief: Shift toward
Partner-Country Treatment Programs Will Require Better Information on
Results, [hyperlink, http://www.gao.gov/products/GAO-13-460]
(Washington, D.C.: Apr. 12, 2013).
[25] GAO, President's Emergency Plan for AIDS Relief: Drug Supply
Chains Are Stronger, but More Steps Are Needed to Reduce Risks,
[hyperlink, http://www.gao.gov/products/GAO-13-483] (Washington, D.C.:
Apr. 26, 2013).
[26] We selected these nonrandom samples based on the type of program
(e.g., prevention, treatment, care, or other) evaluated as well as the
country or countries addressed by each evaluation.
[27] We randomly selected a sample of the 436 evaluations submitted by
CDC and USAID officials in 31 PEPFAR countries and three regions to
allow us to generalize to the entire set of evaluations provided by
PEPFAR country and regional teams.
[28] GAO, President's Emergency Plan for AIDS Relief: Agencies Can
Enhance Evaluation Quality, Planning, and Dissemination, [hyperlink,
http://www.gao.gov/products/GAO-12-673] (Washington, D.C.: May 31,
2012).
[29] Pub. L. No. 110-293, § 301(e).
[30] See GAO, Results-Oriented Government: GPRA Has Established a
Solid Foundation for Achieving Greater Results, [hyperlink,
http://www.gao.gov/products/GAO-04-38] (Washington, D.C.: Mar. 10,
2004).
[31] President's Emergency Plan for AIDS Relief: Program Planning and
Reporting, [hyperlink, http://www.gao.gov/products/GAO-11-785]
(Washington, D.C.: July 29, 2011).
[End of section]
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